The U.S. Food and Drug Administration granted approval for the commercialization of Eli Lilly and Company and Incyte Corporation’s Olumiant (baricitinib), setting a precedent for COVID-19 treatments.
Novartis’ Sandoz business unit saw a strong financial performance in the first quarter of 2022, with overall sales growth of 8 percent, mostly outside of the United States. Sales for the generics and biosimilar unit benefited from what the company called a normalization of the impacts of COVID-19.
The U.S. Food and Drug Administration approved BioXcel Therapeutics Inc.’s IGALMI (dexmedetomidine) sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.
The U.S. Food and Drug Administration approved Gilead Company Kite’s Yescarta (axicabtagene ciloleucel) CAR T-cell therapy for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.
The U.S. Food and Drug Administration approved Merck’s anti-PD-1 therapy Keytruda as a single agent for the treatment of patients with advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
The U.S. Food and Drug Administration approved AbbVie’s Rinvoq (upadacitinib) for adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers.
AstraZeneca and Merck & Co. Inc. announced Lynparza (olaparib) was approved in the United States for the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm) HER2-negative high-risk early breast cancer who have already been treated with chemotherapy either before or after surgery.
Medicago’s vaccine on February 24 became the world’s first plant-based shot approved against COVID-19 after Health Canada cleared Covifenz for use in adults.
Each new president enters the White House with big dreams and unique challenges. For President Joe Biden, 2021 was dominated by the evolving COVID-19 pandemic, an historically difficult transition of power, and a focus on packing an ambitious combination of economic relief, infrastructure investment, and social spending initiatives into a handful of multi-trillion dollar omnibus bills to push through a tightly-divided Congress.
ViiV Healthcare’s HIV treatment Cabenuva was approved by the U.S. Food and Drug Administration for use every two months, meaning patients only have to receive an injectable dose six times per year.